# FDA 483 - Primera Analytical Solutions Corp. - January 23, 2017

Source: https://www.keypedia.com/records/483/primera-analytical-solutions-corp/0b34301c-1217-4687-b48e-1b95503793df

> FDA 483 for Primera Analytical Solutions Corp. on January 23, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primera Analytical Solutions Corp.
- Inspection Date: 2017-01-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Primera Analytical Solutions Corporation in Princeton, New Jersey, identified significant deficiencies in the firm's control laboratory operations. Observations included a lack of detailed written procedures for handling electronic records and inadequate employee training regarding record-keeping responsibilities. These issues indicate a need for improved quality system controls.

## Related Documents

- [EIR - 2015-06-02](https://www.keypedia.com/records/eir/primera-analytical-solutions-corp/c36187a2-83c9-4d3e-969a-4ab8a1274f93)
- [EIR - 2017-01-23](https://www.keypedia.com/records/eir/primera-analytical-solutions-corp/a9ce775d-8677-4993-bed7-5cb13bc09af3)
- [483 - Unknown Date](https://www.keypedia.com/records/483/primera-analytical-solutions-corp/68f6f353-a601-49c2-b8a3-44b0f56db2cf)

## Related Officers

- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

Company: https://www.keypedia.com/companies/primera-analytical-solutions-corp/c4729b68-8ba6-46a7-a7b8-852f38c6625f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248